# C_2013164EN.01002001.xml

| 8.6.2013 | EN | Official Journal of the European Union | C 164/20 |
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8.6.2013

EN

Official Journal of the European Union

C 164/20

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Action brought on 3 April 2013 — PP Nature-Balance Lizenz v Commission

(Case T-189/13)

2013/C 164/36

Language of the case: German

Parties

Parties

Applicant: PP Nature-Balance Lizenz GmbH (Hamburg, Germany) (represented by: M. Ambrosius, lawyer)

Applicant:

Defendant: European Commission

Defendant:

Form of order sought

Form of order sought

| — | Annul the Implementing Decision of the European Commission C(2013) 369 final of 21 January 2013 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for the medicinal products for human use which contain the active substance ‘tolperisone’; |
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Annul the Implementing Decision of the European Commission C(2013) 369 final of 21 January 2013 concerning, in the framework of Article 31 of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for the medicinal products for human use which contain the active substance ‘tolperisone’;

| — | In the alternative, annul the Implementing Decision of the European Commission C(2013) 369 final of 21 January 2013 to the extent that it requires the Member States to remove the therapeutic indication ‘painful muscle spasms particularly as a result of diseases of the spine and paraxial joints’ of the authorisations for tolperisone in oral formulation and to amend the authorisations accordingly; |
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In the alternative, annul the Implementing Decision of the European Commission C(2013) 369 final of 21 January 2013 to the extent that it requires the Member States to remove the therapeutic indication ‘painful muscle spasms particularly as a result of diseases of the spine and paraxial joints’ of the authorisations for tolperisone in oral formulation and to amend the authorisations accordingly;

| — | Order the Commission to pay the costs. |
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Order the Commission to pay the costs.

Pleas in law and main arguments

Pleas in law and main arguments

In support of the action, the applicant relies on three pleas in law.

| 1. | First plea, alleging infringement of Article 116 of Directive 2001/83/EC (1)

  In this context it is claimed inter alia that the contested decision is based on an incorrect assessment of the criterion of lack of therapeutic efficacy. In addition the applicant argues that the wrong criteria were used when making the benefit-risk assessment of tolperisone in oral formulation. |
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First plea, alleging infringement of Article 116 of Directive 2001/83/EC (1)

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In this context it is claimed inter alia that the contested decision is based on an incorrect assessment of the criterion of lack of therapeutic efficacy. In addition the applicant argues that the wrong criteria were used when making the benefit-risk assessment of tolperisone in oral formulation.

| 2. | Second plea, alleging infringement of Article 10a of and Annex I to Directive 2001/83/EC
  The applicant claims in this regard that the contested decision fails to take into account the criteria contained in Article 10a of and Annex I to Directive 2001/83/EC in the evaluation of efficacy and safety and in its benefit-risk assessment. To that extent too the contested decision is based according to the applicant on the use of incorrect standards of assessment. |
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2.

Second plea, alleging infringement of Article 10a of and Annex I to Directive 2001/83/EC

The applicant claims in this regard that the contested decision fails to take into account the criteria contained in Article 10a of and Annex I to Directive 2001/83/EC in the evaluation of efficacy and safety and in its benefit-risk assessment. To that extent too the contested decision is based according to the applicant on the use of incorrect standards of assessment.

| 3. | Third plea, alleging the infringement of the principle of proportionality and of Article 22a(1)(b) of Directive 2001/83/EC
  The applicant claims in the context of this third plea that, instead of amending the authorisations affected with immediate effect, an efficacy study within the meaning of Article 22(a)(1)(b) of Directive 2001/83/EC should have been ordered as a less intrusive measure. The applicant claims that the Commission did not address this possibility with sufficient rigour and that it was rejected by the scientific committee for medicinal products for human use of the EMA [European Medicines Agency] on grounds which are not legally sound. |
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3.

Third plea, alleging the infringement of the principle of proportionality and of Article 22a(1)(b) of Directive 2001/83/EC

The applicant claims in the context of this third plea that, instead of amending the authorisations affected with immediate effect, an efficacy study within the meaning of Article 22(a)(1)(b) of Directive 2001/83/EC should have been ordered as a less intrusive measure. The applicant claims that the Commission did not address this possibility with sufficient rigour and that it was rejected by the scientific committee for medicinal products for human use of the EMA [European Medicines Agency] on grounds which are not legally sound.

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(1)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67)

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